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New Psychiatric Medications Knowledge is Power Gregory T. Bogart, Pharm.D., BCPP Clinical Psychiatric Pharmacist University of Maryland, School of Pharmacy.

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Presentation on theme: "New Psychiatric Medications Knowledge is Power Gregory T. Bogart, Pharm.D., BCPP Clinical Psychiatric Pharmacist University of Maryland, School of Pharmacy."— Presentation transcript:

1 New Psychiatric Medications Knowledge is Power Gregory T. Bogart, Pharm.D., BCPP Clinical Psychiatric Pharmacist University of Maryland, School of Pharmacy Springfield Hospital Center Sykesville, MD Jennifer Miller, Pharm.D., BCPP Clinical Psychiatric Pharmacist Wilkes-Barre VAMC Wilkes-Barre, PA

2 Objectives Discuss clinical indications of new and emerging psychiatric medications Compare and contrast the role of new medications with existing medications Implement strategies to learn about new psychiatric medications

3 Antipsychotics

4 Oral Antipsychotics 1 st Generation2 nd Generation Thorazine ® (chlorpromazine)Clozaril ® (clozapine) Haldol ® (haloperidol)Risperdal ® (risperidone) Prolixin ® (fluphenazine)Geodon ® (ziprasidone) Stelazine ® (trifluperazine)Seroquel ® (quetiapine) Trilafon ® (perphenazine)Zyprexa ® (olanzapine) Navane ® (thiothixene)Abilify ® (aripipirazole) Loxitane ® (loxapine)Invega ® (paliperidone) Mellaril ® (thioridazine)Fanapt ® (Iloperidone) Saphris ® (Asenapine) Latuda ® (Lurasidone)

5 Long Acting Injectable Antipsychotics 1 st Generation2 nd Generation Haloperidol decanoateRisperdal Consta ® Fluphenazine decanoateInvega Sustenna ® Zyprexa Relprevv ® Abilify Maintena ®

6 NEW ORAL ANTIPSYCHOTICS

7 Iloperidone FDA approved in 2009 Indicated for the treatment of schizophrenia in adults Mechanism of action – primarily dopamine (D 2 ) antagonism with some serotonin (5HT 2 ) antagonism Fanapt ® [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corporation; Revised April, 2014.

8 Iloperidone - Efficacy 6-week trial with placebo and risperidone showed superiority over placebo and comparable efficacy of risperidone at 6 weeks 4-week trial with placebo and ziprasidone found superiority over placebo and similar efficacy to ziprasidone at 4 weeks Fanapt ® [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corporation; Revised April, 2014.

9 Iloperidone – Possible Side Effects Metabolic changes – weight gain, ↑cholesterol –Not as significant as other 2 nd gen drugs Extrapyramidal symptoms (EPS) QTc prolongation Orthostasis, low blood pressure, and dizziness Rarer side effects – priapism, seizure, agranulocytosis

10 Iloperidone - Dosing Starting dose 1 mg twice daily Target dosage range 6-12 mg twice daily Increase by no more than 2 mg twice daily every day until target range –Slow titration due to increased risk of low blood pressure, dizziness, and falls Maximum dose of 12 mg twice daily Fanapt ® [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corporation; Revised April, 2014.

11 Iloperidone – Role in therapy New second generation antipsychotic choice Lower risk for EPS and weight gain than other options Higher risk of orthostasis, dizziness, and falls especially during the initial titration phase Slow titration phase and twice daily dosing may be difficult for some patients to work with

12 Asenapine FDA approved in 2009 Indications –Treatment of schizophrenia in adults –Acute treatment, either as monotherapy or adjunctive, or manic or mixed episodes of bipolar I disorder in adults Mechanism of action thought to be a combination of dopamine D 2 and serotonin 5HT 2 receptor blockade Saphris ® [package insert]. Whitehouse Station, NJ; Merck & Co., Inc.; Revised March, 2013.

13 Asenapine – Efficacy in Schizophrenia Short term studies 1.A 6-week trial comparing asenapine to placebo showed superior efficacy asenapine at 6 weeks 2.A 6-week trial comparing asenapine to placebo and haloperidol showed asenapine to be superior to placebo, but not haloperidol. It also showed no difference between 5 mg twice daily and 10 mg twice daily dosing 3.A 6-weeks trial comparing asenapine to placebo olanzapine showed that asenapine and placebo failed to separate and that olanzapine was superior to both Saphris ® [package insert]. Whitehouse Station, NJ; Merck & Co., Inc.; Revised March, 2013.

14 Asenapine – Efficacy in Bipolar I Disorder Monotherapy –Two 3-week trials of asenapine and placebo showed that asenapine was superior to placebo for controlling acute mania Adjunctive –A 12-week trial of asenapine or placebo added to lithium or valproic acid showed asenapine was superior to placebo at reducing manic symptoms at 3 weeks Saphris ® [package insert]. Whitehouse Station, NJ; Merck & Co., Inc.; Revised March, 2013.

15 Asenapine – Possible Side Effects Metabolic changes and weight gain –Not as significant as other 2 nd gen drugs EPS – higher rates of akathisia QTc prolongation Sedation or somnolence Headache Rarer side effects – agranulocytosis, seizures, and orthostasis Saphris ® [package insert]. Whitehouse Station, NJ; Merck & Co., Inc.; Revised March, 2013.

16 Asenapine - Dosing IndicationStarting DoseDosage RangeMaximum Schizophrenia5 mg twice daily5-10 mg twice daily10 mg twice daily Acute Bipolar I10 mg twice daily5-10 mg twice daily10 mg twice daily Asenapine is supplied as sublingual tablets –Do not swallow tablets –Dissolve under the tongue –No food or drink for 10 minutes after dose Saphris ® [package insert]. Whitehouse Station, NJ; Merck & Co., Inc.; Revised March, 2013.

17 Asenapine – Role in Therapy Can be utilized in both schizophrenia and bipolar disorder Unique sublingual administration Relatively small metabolic side effects Higher rates of sedation and akathisia than other agents

18 Lurasidone FDA approved in 2010 Indications –Treatment of schizophrenia in adults –Treatment of depressive episodes in bipolar disorder in adults as both monotherapy and adjunctive therapy Mechanism of action thought to be a combination of dopamine D 2 and serotonin 5HT 2 receptor blockade Latuda ® [package insert]. Marlborough, MA; Sunovion Pharmaceuticals, Inc.; Revised July, 2013.

19 Lurasidone – Efficacy in Schizophrenia Five total trials, all 6 weeks long –Two trials of fixed dose lurasidone vs. placebo showed superior efficacy of lurasidone –One trial of 40 mg, 80 mg, and 120 mg lurasidone vs. placebo showed that only the 80 mg dose was superior to placebo –One trial of lurasidone, olanzapine and placebo showed that both lurasidone and olanzapine were superior to placebo –One trial of lurasidone, quetiapine ER, and placebo showed both lurasidone and quetiapine ER were superior to placebo Latuda ® [package insert]. Marlborough, MA; Sunovion Pharmaceuticals, Inc.; Revised July, 2013.

20 Lurasidone – Efficacy in Bipolar Depression As monotherapy –A 6-week trial vs placebo for symptom reduction in bipolar depression showed that both doses of lurasidone studied were superior to placebo at 6 weeks As an adjunct –A 6-week trial of patients who were still symptomatic on lithium or valproic acid were given placebo or lurasidone. At 6 weeks, there was a superior symptom reduction in the lurasidone group vs. the placebo group Latuda ® [package insert]. Marlborough, MA; Sunovion Pharmaceuticals, Inc.; Revised July, 2013.

21 Lurasidone – Possible Side Effects Metabolic changes and weight gain –Possibly the most weight and metabolic neutral EPS – akathisia more common than others QTc prolongation Sedation or somnolence Nausea and vomiting Rarer side effects – agranulocytosis, seizures, and orthostasis Latuda ® [package insert]. Marlborough, MA; Sunovion Pharmaceuticals, Inc.; Revised July, 2013.

22 Lurasidone - Dosing For schizophrenia, starting dose is 40 mg/day with a range of mg/day For bipolar depression, starting dose is 20 mg/day with a range of mg/day All doses should be taken with a meal of at least 350 calories to improve absorption Dosing is recommended in the evening due to the possibility of sedation and somnolence Latuda ® [package insert]. Marlborough, MA; Sunovion Pharmaceuticals, Inc.; Revised July, 2013.

23 Lurasidone – Role in Therapy Can be utilized in schizophrenia and bipolar depression Has a very favorable long-term metabolic profile Once daily dosing is most patient friendly Appears to be the most rigorously studied of the newer agents

24 LONG ACTING INJECTIONS (LAIS)

25 Rationale LAIs are options to improve compliance –Less frequent administration than oral agents –Doses converted from stable oral regimens –Guaranteed drug level in the body post-injection –Improved clinician contact

26 Available Options 1 st Generation2 nd Generation Haloperidol decanoateRisperdal Consta ® Fluphenazine decanoateInvega Sustenna ® Zyprexa Relprevv ® Abilify Maintena ®

27 Zyprexa Relprevv ® FDA approved in 2009 Long acting intramuscular injection of olanzapine intended for gluteal injection only Indicated for the treatment of schizophrenia Designed to be initiated after a stable regimen of olanzapine is established Zyprexa Relprevv ® [package insert]. Indianapolis, IN; Eli Lilly and Company; Revised July, 2011.

28 Zyprexa Relprevv ® - Dosing Oral dose of olanzapineDose of Zyprexa Relprevv ® for the first 8 weeks Maintenance dose of Zyprexa Relprevv ® after 8 weeks 10 mg/day210 mg every 2 weeks or 405 mg every 4 weeks 150 mg every 2 weeks or 300 mg every 4 weeks 15 mg/day300 mg every 2 weeks210 mg every 2 weeks or 405 mg every 4 weeks 20 mg/day300 mg every 2 weeks Note: No oral medication overlap is required Zyprexa Relprevv ® [package insert]. Indianapolis, IN; Eli Lilly and Company; Revised July, 2011.

29 Adverse Events Adverse events are similar to oral olanzapine –Metabolic syndrome and weight gain –Sedation –Orthostasis and dizziness Also has Post-Injection Delirium/Sedation Syndrome (PDSS) risk Zyprexa Relprevv ® [package insert]. Indianapolis, IN; Eli Lilly and Company; Revised July, 2011.

30 PDSS Signs and symptoms associated with olanzapine overdose –Sedation and/or delirium possibly leading to coma –Dizziness, confusion, disorientation, slurred speech, weakness, difficulty walking –Occurred in <0.1% of all injections, 2% of all patients treated in 46 months –Most patients recovered with supportive care within 72 hours –Lead to the creation of a REMS program Zyprexa Relprevv ® [package insert]. Indianapolis, IN; Eli Lilly and Company; Revised July, 2011.

31 Zyprexa Relprevv ® REMS Prescriber, patient, facility, and pharmacy must all register Medication cannot be dispensed directly to patient Medication must be administered in a registered facility with access to emergency response services Patients must be observed by a healthcare worker for at least 3 hours after injection for signs of PDSS Patients may not leave the facility by themselves Patients should not drive the remainder of the day Zyprexa Relprevv ® [package insert]. Indianapolis, IN; Eli Lilly and Company; Revised July, 2011.

32 Abilify Maintena ® FDA approved in 2013 Long acting intramuscular injection of aripiprazole intended for gluteal injection only Indicated for the treatment of schizophrenia Designed to be initiated after a stable regimen of aripiprazole is established Abilify Maintena ® [package insert]. Tokyo, Japan; Otsuka Pharmaceutical Co. Ltd; Revised February, 2013.

33 Abilify Maintena ® Dosing Recommended starting dose in 400 mg monthly Continuation of oral aripiprazole mg/day is necessary for 14 days after initial injection Maintenance dose is also 400 mg monthly –Dose reduction to 300 mg can be used if 400 mg dose is intolerable Abilify Maintena ® [package insert]. Tokyo, Japan; Otsuka Pharmaceutical Co. Ltd; Revised February, 2013.

34 Adverse Events Very similar to oral aripiprazole –Slight metabolic changes –Some EPS – mostly akathisia –Anxiety –Headache –Orthostasis Abilify Maintena ® [package insert]. Tokyo, Japan; Otsuka Pharmaceutical Co. Ltd; Revised February, 2013.

35 Antidepressants

36 Selective Serotonin Reuptake Inhibitors (SSRIs) Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) Celexa ® (citalopram)Cymbalta ® (duloxetine) Lexapro ® (escitalopram)Effexor ® (venlafaxine) Prozac ® (fluoxetine)Pristiq ® (desvenlafaxine) Paxil ® (paroxetine)Savella ® (milnacipran) Luvox ® (fluvoxamine)Fetzima ® (levomilnacipran) Zoloft ® (sertraline) Brintellix ® (vortioxetine) Viibryd ® (vilazodone)

37 Antidepressants Tricyclic AntidepressantsAtypical Antidepressants Monoamine Oxidase Inhibitors (MAOIs) Elavil ® (amitriptyline)Wellbutrin ® (bupropion)Nardil ® (phenelzine) Anafranil ® (clomipramine)Remeron ® (mirtazapine)Parnate ® (tranylcypromine) Tofranil ® (imipramine)Serzone ® (nefazodone)Eldepryl ® (selegiline) Pamelor ® (nortriptyline)Desyrel ® (trazodone)Marplan ® (isocarboxazid)* Norpramin ® (desipramine) Sinequan ® (doxepin) Vivactil ® (protriptyline)

38 NEW ORAL ANTIDEPRESSANTS

39 Viibryd ® (Vilazodone) Year Approved –2011 Indication –Major Depressive Disorder Image from Viibryd ® [package insert]. St. Louis, MO; Forest Laboratories, Inc.; Revised December, 2012.

40 Viibryd ® (Vilazodone) Mechanism of Action –Selective Serotonin Reuptake Inhibitor (SSRI) –Activity at serotonin receptor Effectiveness –Decreased depressive symptoms in 8 week trials better than placebo Viibryd ® [package insert]. St. Louis, MO; Forest Laboratories, Inc.; Revised December, 2012.

41 Viibryd ® (Vilazodone) Safety –Contraindications Use with MAOI –Warnings Serotonin syndrome, suicidality, seizure, mania, bleed, low sodium, sudden discontinuation Viibryd ® [package insert]. St. Louis, MO; Forest Laboratories, Inc.; Revised December, 2012.

42 Viibryd ® (Vilazodone) Safety –Drug interactions –Adverse Effects Nausea, diarrhea, dizziness, sleep disturbance, sexual dysfunction Viibryd ® [package insert]. St. Louis, MO; Forest Laboratories, Inc.; Revised December, 2012.

43 Viibryd ® (Vilazodone) Considerations for Use –Take with food –Dose titration –No dose adjustment for age –Pregnancy, nursing, or children Medication Role –No clear advantage over SSRIs for depression Viibryd ® [package insert]. St. Louis, MO; Forest Laboratories, Inc.; Revised December, 2012.

44 Fetzima ® (Levomilnacipran) Year Approved –2013 Indication –Major Depressive Disorder Image from Fetzima ® [package insert]. St. Louis, MO; Forest Laboratories, Inc.; Revised July, 2013.

45 Fetzima ® (Levomilnacipran) Mechanism of Action –Serotonin Norepinephrine Reuptake Inhibitor (SNRI) Effectiveness –Decreased depressive symptoms in 8 week trials better than placebo Fetzima ® [package insert]. St. Louis, MO; Forest Laboratories, Inc.; Revised July, 2013.

46 Fetzima ® (Levomilnacipran) Safety –Contraindications Allergic reaction, uncontrolled narrow-angle glaucoma, use with MAOI –Warnings Serotonin syndrome, suicidality, seizure, mania, bleed, low sodium, sudden discontinuation Fetzima ® [package insert]. St. Louis, MO; Forest Laboratories, Inc.; Revised July, 2013.

47 Fetzima ® (Levomilnacipran) Safety –Warnings (cont.) High blood pressure & heart rate, narrow-angle glaucoma, urinary hesitation or retention –Drug interactions –Adverse Effects Nausea, vomiting, constipation, sweating, increased blood pressure & heart rate, sexual dysfunction Fetzima ® [package insert]. St. Louis, MO; Forest Laboratories, Inc.; Revised July, 2013.

48 Fetzima ® (Levomilnacipran) Considerations for Use –Adjust dose for kidney impairment –No dose adjustment for age –Pregnancy, nursing, children Medication Role –No clear advantage over SNRIs for depression –No established effectiveness for fibromyalgia/ pain Fetzima ® [package insert]. St. Louis, MO; Forest Laboratories, Inc.; Revised July, 2013.

49 Brintellix ® (Vortioxetine) Year Approved –2013 Indication –Major Depressive Disorder Image from us.brintellix.com Brintellix ® [package insert]. Deerfield, IL; Takeda Pharmaceuticals America, Inc.; Revised July, 2014.

50 Brintellix ® (Vortioxetine) Mechanism of Action –SSRI –Activity at various serotonin receptors Effectiveness –Decreased depressive symptoms in 6-8 week trials & longer time to recurrent depression in 64 week trial better than placebo Brintellix ® [package insert]. Deerfield, IL; Takeda Pharmaceuticals America, Inc.; Revised July, 2014.

51 Brintellix ® (Vortioxetine) Safety –Contraindications Allergic reaction, use with MAOI –Warnings Serotonin syndrome, suicidality, mania, bleed, low sodium Brintellix ® [package insert]. Deerfield, IL; Takeda Pharmaceuticals America, Inc.; Revised July, 2014.

52 Brintellix ® (Vortioxetine) Safety –Drug interactions –Adverse Effects Nausea, vomiting, constipation, dizziness, sexual dysfunction Brintellix ® [package insert]. Deerfield, IL; Takeda Pharmaceuticals America, Inc.; Revised July, 2014.

53 Brintellix ® (Vortioxetine) Considerations for Use –Avoid in severe liver impairment –No dose adjustment for age –Pregnancy, nursing, children Medication Role –No clear advantage over SSRIs for depression Brintellix ® [package insert]. Deerfield, IL; Takeda Pharmaceuticals America, Inc.; Revised July, 2014.

54 Miscellaneous Medications

55 Images taken from

56 Learning Strategies

57 Resources NAMI.org –Medication fact sheets FDA.gov Drugs.com MedlinePlus Narsad.org

58


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